For the use of Registered Medical Practitioners (Specialist in Medicine) or a Hospital or a Laboratory only

Infusion Protocol
INDICATION: Cerezyme® is indicated for use as long-term enzyme
replacement therapy in patients with a confirmed diagnosis of
non-neuronopathic (Type 1) or chronic neuronopathic (Type 3)
Gaucher disease who exhibit clinically significant non-neurological
manifestations of the disease
Imiglucerase for Injection 400 units

Cerezyme Dosage Dosage Calculation (illustration):

 Dose - 60 U/kg every 2 weeks as an IV infusion
Patient weight in
 Total volume of Infusion determined by the patient’s weight kg × 60 U/kg = total dose in U 1.5 Vial
 Each vial contains 400 U Cerezyme.
Shelf life of Unopened vials:3 years
 Round up the number if no. of vials in fraction
10 kg patient weight × 60
U/kg = 600 U patient dose
600 U / 400 U vial = 1.5 vials

Reconstitution and Dilution Administration

 Allow vials to reach room temperature (30 minutes)
1  Don’t infuse in same IV line for other products.
 Reconstitute each vial with 10 ml Sterile water (40 units imiglucerase per ml)

 Slow drop wise injection down the inside wall of the vial (not directly onto the lyophilized cake)
2  Total time of infusion around 1-2 hours, can be up to 3 hours.
 Tilt and roll vial gently (Don’t invert and shake)

 Check for any particulate matter or discoloration

3  Dosage can be individualized if required
 Protect from direct sunlight

 Slowly withdraw the reconstituted solution from vial

4  Cerezyme® is supplied as a sterile, non-pyrogenic, lyophilized product
 Dilution in 0.9% NaCl and make final volume to a total volume of 100 to 200 ml.

5  Prepare the infusion and label it  Not to reconstitute the product until patient’s venous line not taken
 Use immediately ( if not, then it can be stored up to 24 hours in 2° to 8° C)

6  Mix the infusion solution gently. Follow the infusion protocol and monitor  Decrease rate or stop the infusion if any infusion reaction

Monitoring
 Check for Vital at 15 minutes, 60 minutes and at the completion of the infusion

 Check for infusion reactions during and up to 2 hours post infusion

 Infusion reaction occurs generally with Higher rates

 At initial infusions, Cerezyme should be administered at a rate not exceeding 0.5 unit per kg body weight per minute. At subsequent administrations,
infusion rate may be increased but should not exceed 1 unit per kg body weight per minute.

 Upon completion, flush the infusion line with 0.9% Sodium Chloride to administer the Cerezyme remaining within the line

Imiglucerase: adverse event profile

COMMON (≥1% to <10%)

 Hypersensitivity reactions Symptoms suggestive of
 Dyspnea, coughing
hypersensitivity were reported
in 3% of imiglucerase-treated patients*
 Urticaria/angioedema, pruritus, rash

UNCOMMON (≥0.1% to <1%)  Vomiting, nausea, abdominal Infusion site-related reactions occurred in <1% of patients
 Dizziness, headache, paresthesia cramping, diarrhea
 Tachycardia, cyanosis  Arthralgia, backache AEs related to the route of administration:
 Flushing, hypotension  Infusion site reactions  Discomfort  Burning  Swelling
 Fevers, rigors, fatigue  Sterile abscess at venipuncture site

*Includes data from clinical trials and post marketing reports

Abridged Prescribing Information For the use only of a Registered Medical Practitioners (Specialist in Medicine) or a Hospital or a Laboratory
MAT-IN-2302720-0.1-12/23

Cerezyme®
Injection400 Units (Imiglucerase for injection)
Powder for Concentrate for Solution for Infusion
Infusion Associated Reactions: Patients may develop infusion associated reactions (IARs). IARs are defined as any related adverse event occurring during the infusion or during the hours
COMPOSITION: Each vial contains Cerezyme 400 U of imiglucerase and the following excipients: mannitol, sodium citrate, citric acid monohydrate and polysorbate 80. following infusion.
THERAPEUTIC INDICATION: Cerezyme® (imiglucerase for injection) is indicated for use as long-term enzyme replacement therapy in patients with a confirmed diagnosis of Pregnancy: Limited experience from 150 pregnancy outcomes (primarily based on spontaneous reporting and literature review) is available suggesting that use of Cerezyme is beneficial
non-neuronopathic (Type 1) or chronic neuronopathic (Type 3) Gaucher disease who exhibit clinically significant non-neurological manifestations of the disease. to control the underlying Gaucher disease in pregnancy. Furthermore, these data indicate no malformative toxicity for the foetus by Cerezyme, although the statistical evidence is low.
DOSAGE & ADMINISTRATION: Therapy should be directed by physicians knowledgeable in the management of Gaucher disease. Initial doses of 60 U/kg of body weight once every Treatment naïve women should be advised to consider commencing therapy prior to conception in order to attain optimal health. In women receiving Cerezyme treatment continuation
2 weeks have shown improvement in haematological and visceral parameters within 6 months of therapy and continued use has either stopped progression of or improved bone throughout pregnancy should be considered. .
disease. Administration of doses as low as 2.5 U/kg of body weight three times a week or 15 U/kg of body weight once every 2 weeks has been shown to improve haematological Lactation: It is not known whether this active substance is excreted in human milk, however, the enzyme is likely to be digested in the child’s gastrointestinal tract.
parameters and organomegaly, but not bone parameters. The reconstituted and diluted preparation is administered by intravenous infusion over 1 to 2 hours. Paediatric ADVERSE REACTIONS: Most common adverse drug reactions are –Dyspnoea, Coughing, Hypersensitivity reactions, urticaria/angioedema, pruritus and rash.
population: No dose adjustment is necessary for the paediatric population.
Method of Administration: After reconstitution and dilution, the preparation is administered by intravenous infusion. At initial infusions, Cerezyme should be administered at a rate For full prescribing information please contact: Sanofi Healthcare India Pvt Ltd,Sanofi House, CT Survey No 117- B, L& T Business Park, Saki Vihar Road, Powai, Mumbai-400072
not exceeding 0.5 unit per kg body weight per minute. At subsequent administrations, infusion rate may be increased but should not exceed 1 unit per kg body weight per minute. Source: EU Summary of Product Characteristics (SmPC) dated March 2017 Date: April 2022
Infusion of Cerezyme at home may be considered for patients who are tolerating their infusions well for several months. Decision to have patient move to home infusion should be
made after evaluation and recommendation by the treating physician.
SAFETY RELATED INFORMATION
Contraindications: Hypersensitivity to the active substance or to any of the excipients.

Warnings & Precautions:

Hypersensitivity/Anaphylactic reactions: As with any intravenous protein product, severe allergic-type hypersensitivity reactions are possible, but occur uncommonly. If these
reactions occur, immediate discontinuation of the Cerezyme infusion is recommended and appropriate medical treatment should be initiated. The current medical standards for
emergency treatment of anaphylactic reactions are to be observed. Patients with antibody to imiglucerase have a higher risk of hypersensitivity reactions

Sanofi Healthcare India Pvt. Ltd., Sanofi House, CT Survey No. 117-B,
Adverse events should be reported at : PV.India@sanofi.com L&T Business Park, Saki Vihar Road, Powai, Mumbai – 400 072